Medical Research Law Michigan

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					Research Involving Human
Ethics, Law and Regulation

      December 2002
     William Beaumont & Alexis St.
   Beaumont carried out a series of experiments on
    Alexis St. Martin over a period of many years

   Was Beaumont a pioneer in ethical research or
    someone who abused his research subject?

    –   Be careful of applying present-day standards to
        historical figures

    –   The prime value of this case lies in what it tells us
        about how to do things today, not whether Beaumont
        was a good or bad man
Beaumont (1785-1853)
   Had a 2 year apprenticeship with a country doctor

   Enlisted as a surgeon‟s mate in 1812. Briefly left the army
    after the War of 1812, but rejoined as a surgeon in 1820

   1822 – Encounters St. Martin

   1833 – Experiments and Observations on the Gastric
    Juices and the Physiology of Digestion

    –   “produced a picture of the living stomach that has required only a little
        updating in the century and a half since he made his observations.”
St. Martin (1803?-1880)
   June 6, 1822 – St. Martin, a French-Canadian working for
    the American Fur Company, was accidentally shot in
    Northern Michigan

   The result was a fistula exposing part of St. Martin‟s lung
    and stomach

   St. Martin survived, but the fistula never closed fully

   After 8-10 months of attempts to close it, Beaumont
    concluded that the only means of doing so was to suture
    the sides together, “an operation to which the patient
    would not submit.”
The Experiments
   First experiment in May, 1823?

    –   Administering a cathartic by pouring it in

   Literally hundreds between 1825 and 1833,
    most involving inserting or removing
    material through the „valve‟ in St. Martin‟s
The Relationship
   1825 – Beaumont carried out experiments from May-
    August then St. Martin “returned to Canada … without
    obtaining my consent.” (18)

    –   In correspondence, Beaumont described this as a “faithless

   1829 – St. Martin enters Beaumont‟s “service” in August

    –   St. Martin “performed all the duties of a common servant” when
        experiments were not being carried out. (19)
    –   This continues until March, 1831, when Beaumont allows St.
        Martin to return home.
The Relationship
   1832 – In October, St. Martin returns.

    –   The two sign a contract binding St. Martin to “obey,
        suffer & comply with all reasonable & proper orders or
    –   In exchange, St. Martin was to receive $150 plus room
        and board.
    –   In 1832, St. Martin was persuaded to join the U.S.
        Army for a period of 5 years. He was eventually
        assigned to Beaumont as an assistant
The Relationship
   1833 – A new contract is signed, for 2 years
    at $200 a year

        Shortly afterward, Beaumont advances St. Martin
         some of the $200 in order for St. Martin to return his
         family to Canada.

        St.Martin never returned, although Beaumont made
         increasingly lucrative offers ($500/year in 1850,
         shortly before Beaumont‟s death)
         Beaumont as Medical Ethics

   Beecher (1970) credits Beaumont with producing the
    “oldest American code” concerning human

    –   “5. The voluntary consent of the subject is necessary…
    –   “6. The experiment is to be discontinued when it causes distress to
        the subject…
    –   7. The project must be abandoned when the subject becomes

   There is, however, some dispute about whether this code
    actually existed. (Numbers, 1979)
                        Some Issues
   When did Beaumont take St. Martin into his home?

    –   Beaumont tells us it was before he began using St. Martin as a
        research subject. Others (Numbers, 1979) say it was after.

   Returning to Canada “without my permission”?

   Some experiments clearly caused St. Martin discomfort

   Payment for participation in research
A. what is research?
B. rationale for research ethics review
C. ethical/legal/regulatory framework
  for human subject research in Canada
D. some major ethical/legal issues in
  biomedical research
What is Research?
   sometimes difficult to distinguish research
    from therapy:
    –   often carried out simultaneously
    –   investigators often physicians
    –   terminology - “therapeutic research”, “clinical
        research”, “experimental interventions”
    –   research vs. “innovative care”
Research and/or Therapy?
   Why is the distinction important?
    –   determines whether particular set of regulations
        or research ethics guidelines must be followed
    –   determines whether prior approval by a
        Research Ethics Board (REB) is required
    –   affects the legal standard for disclosure of
    –   may affect ability of substitute decision-maker
        to give consent
         What is Human Subject
   “the generation of data about persons,
    through intervention or otherwise, that goes
    beyond that necessary for the person‟s
    immediate well-being”
        1987   MRC Guidelines
   an activity that involves “a systematic
    investigation to establish facts, principles or
    generalizable knowledge”
        1998 Tri-Council Policy Statement: Ethical Conduct
         of Research Involving Humans
    Rationale For Research Ethics
 part of crucial system of checks and
 safeguard rights and well-being of research
 address actual, perceived, potential conflicts
  of interest
 reinforce and rehabilitate public trust in
  medical research
    Rationale For Research Ethics
 inherent tension between primary aims of
  research and treatment
 when patients participate in clinical
  research, physician-investigator may
  experience this tension
 notion of “clinical equipoise”:
    - RCT‟s ethically acceptable where expert community in state of
      honest professional disagreement as to relative merits of two
Research Codes and Guidelines
 primary purpose - to protect the physical
  well-being, dignity and integrity of
  individuals who serve as participants
 interests of investigators in pursuing their
 interests of society in increasing knowledge
  re public and individual health
          Historical Context
 will be covered in future session
 several instances of research controversies
  and atrocities in many different countries
 a number of international instruments have
  been developed to try to address ethical
  standards and regulation of human subject
    Governance of Human Subject
        Research in Canada
   in Canada, no comprehensive legislation to
    regulate all research involving humans
- biomedical research governed by law that is primarily
  directed to other purposes
- some legislation applies almost inadvertently to research
- other legislation re health care deliberately excludes
  research from its ambit
- role of the common law- consent, negligence, etc.
- Quebec - Civil Code
Newfoundland Legislation
   some statutes in NF containing provisions
    applicable to research:
- Advance Health Care Directives Act
- Access to Information and Protection of Privacy Act
- Hospitals Act
- Human Tissue Act
Codes, Guidelines and Policies
   these “extra-legal instruments” play important role
    in regulation of research in Canada
   promulgated by governmental bodies, funding
    agencies, professional organizations and local
   ethics codes, guidelines and policy statements
    usually lack means of direct legal enforcement
   however may be relied on by courts to indicate
    applicable standards of conduct
    Tri-Council Policy Statement on the Ethical
      Conduct of Research Involving Human
                 Subjects (1998)
   context - the need for research, guiding ethical principles,
    “subject-centered perspective”
   research requiring ethics review, REB‟s
   consent, confidentiality, conflict of interest
   inclusion in research - women, incompetent individuals,
    aboriginal people
   clinical trials
   human genetic research, research on embryos/fetuses and
    human tissues
         CMA Code of Ethics
 duty of physicians to obtain from research
  ethics committee review and approval of
  research involving humans
 duty of physicians to obtain informed
  consent from potential research subjects
 duty to report unethical research behaviour
Some Major Ethical/Legal Issues
     in Medical Research
1.   conflicts of interest
2.   consent - informed, voluntary
3.   confidentiality, access to information
4.   scope of acceptable research
5.   children, mentally incompetent individuals
6.   justice in recruitment of subjects
            Conflicts of Interest
   investigator‟s interests
- fame, publishable results, medical breakthroughs to benefit
   financial conflicts of interest
- pharmaceutical companies
- partnerships between academic institutions and corporations
- commercial value of research results
Conflicts of Interest and REB‟s
   one role of REB‟s is conflict of interest
- financial conflicts
- impact of conflicts on informed consent
   conflicts of interest involving the REB:
- membership, operation within institution
- collegiality, concerns about promotion, bringing valuable
   research funding into institution, etc.
Consent - General Principles
   capacity
- must be given by person legally capable of making decision
   voluntary
- no coercion/undue influence
   specific
- to procedure(s), physician(s) involved
   informed
- disclosure/discussion required
         Consent to Research
            in the Courts
 two categories of research dealt with
  differently by the courts:
1. consent to research with no intended benefit
  for participants
2. consent to research with intended benefit
  with participants
      Research with no Intended
       Benefit for Participants
Halushka v. U. of Saskatchewan (Sask. C.A. 1965)
- healthy university student paid $50 to participate in
    anesthetic drug trial, requiring cardiac catheterization
- told test was “nothing to worry about”
- suffered cardiac arrest, residual injuries
Court held: duty of disclosure of investigators at least as great
    as, if not greater than, duty of ordinary physician/surgeon
    to patient
- full and frank disclosure
- no “therapeutic privilege”, no waiver
      Research with no Intended
       Benefit for Participants
Weiss v. Solomon (Que. Sup. Ct. 1989)
- trial of ophthalmic drops in reducing post-op retinal edema
- fluorescein angiography used to verify effects of drops
- told risks: discomfort, nausea and minor allergic reactions
- patient died from severe allergic reaction
Court held: investigator and REB at fault for failure to warn
    of all the risks involved in the research
- all risks must be disclosed, even if rare/remote, particularly
    if serious consequences
- court based decision in part on Helsinki Declaration
    Research with Intended Benefit
           for Participants
   no Canadian cases involving research pursuant to
    protocol reviewed for ethical/scientific merit
   cases involving individual MDs testing therapeutic
    innovations of their own design in course of Dr.-
    pt. relationship
   courts have applied standard of disclosure
    generally applied to Dr.-pt. relationship - “What
    would reasonable pt. want to know?
   fact that procedure “unique” or “experimental”
    something most people would want to know
 general obligation of confidentiality owed
  by physicians to patients extends to
 embodied in research codes, guidelines
 REB‟s typically require policies re storage
  and destruction of data and samples,
  anonymization of data
 should also be addressed in consent forms
 tension between need to share data and
  privacy of subjects
 beware of over-promising confidentiality:
    - access to data for safety and ethics monitoring
        - Health Protection Branch, Health Canada
        - periodic review by REB‟s
    - genetic research
        - right to know/right not to know?
        - duty/right to inform relatives of their risks?

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